Neuron AccuPoint™ Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain.

Device Description

The AccuPoint™ Electrode is used for monitoring, recording, or microstimulation during intraoperative procedures to map the electrical activity of single unit neurons at subsurface levels of the brain. Intraoperative microelectrode recording (MER) and microstimulation equipment is utilized with depth electrodes during stereotactic surgery to assist in localization for further applications such as permanent implant placement.

The MER or microstimulation equipment which connects to the AccuPoint Electrode are supplied by other manufacturers and is not sold by MicroProbes for Life Science, Inc. The AccuPoint Electrode is produced with standard connectors to connect with other manufacturers' cables that then connect to MER and microstimulation equipment.

The AccuPoint Electrode is a long, extremely thin metal needle insulated with a Parylene C coating. This needle will be composed of either tungsten or a platinum-iridium alloy, depending on the preference of the clinician. The tip of this needle is exposed using either an electric arc or laser process, to create an electrode. The tip exposure length can be carefully controlled to imbue the electrode with a particular impedance. This core needle electrode is situated within a stainless steel and polyimide cannula, with the electrode and cannula being employed together as an integrated unit. The electrode will be capable of sliding within the cannula. allowing the clinician to extend the tip during use, or retract the tip back within the cannula during handling and storage. The rear portion of the cannula will be equipped with a "stop collar", or a thick stainless steel ring which assures proper placement of the electrode within the surgical frame. A laver of stainless steel within the cannula will serve as a second electrode or "reference contact". The electrode may or may not be equipped with an outer stainless steel shield. The electrode will be equipped with two gold pin connectors on the back end, which allow the electrode to be connected to the cable leading to the MER or microstimulation equipment possessed by the surqeon. The model number of each electrode configuration was chosen to be analogous to the comparable predicate electrode model from one of two other manufacturers (FHC and Alpha Omega), allowing clinicians to easily adopt the AccuPoint Electrode with minimal confusion. Only a length within 5 cm of the AccuPoint Electrode comes into direct contact with patient tissue.

Accessories include stainless steel spacer and insertion tubes and stylets which are used during stereotaxic functional neurosurgical procedures to accurately guide a microelectrode or instrument into the brain. The insertion tubes with the stylet inserted are initially placed through the stereotaxic frame access locations for determining the estimated depth of the target location to then insert the depth electrode (AccuPoint Electrode).

The AccuPoint Electrodes and Accessories will be sold sterile, for single patient use, and will be disposable.

AI/ML Overview

The provided document K162459 for the Accupoint Electrode does not contain information about studies specifically designed to prove the device meets acceptance criteria related to a diagnostic or AI-driven performance measure. This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel diagnostic or AI functionality.

The "Summary of Testing" section (page 5) details the types of tests performed for the AccuPoint Electrode, but these are primarily engineering and biocompatibility tests to ensure the device's basic safety and function, and its equivalence to the predicate device. They do not involve clinical performance metrics like sensitivity, specificity, or reader improvement with AI assistance.

Therefore, many of the requested elements of the acceptance criteria and study information cannot be extracted from this document, as they are not relevant to the type of device and its regulatory submission.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity). Instead, it focuses on demonstrating that the device's characteristics are comparable to the predicate device and that it meets basic safety and performance requirements for an electrode.

Characteristic / Test	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (K162459)
Indications For Use	Same as predicate device (FHC microTargeting Electrode)	"Neuron AccuPoint™ Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain." (Matches predicate)
Material Biocompatibility	Meets ISO 10993-1 requirements; no cytotoxicity	Cytotoxicity testing completed, compliance maintained with known biocompatible materials and validated sterilization processes.
Electrode Impedance	Within specified range (0.5 MΩ-Megohms (+/-30%) to 1 MΩ-Megohms (+/-20%) Measured at 1 kHz or 220 Hz)	Tested for electrode impedance. (No specific numerical results reported in this summary, but implied to meet criteria for substantial equivalence).
Continuity and Insulation Integrity	Functionally sound, no breaks in continuity or insulation defects	Tested for continuity and insulation integrity. (Implied to meet criteria).
Dynamic Impedance	No short circuiting between inner and outer electrodes	Tested for dynamic impedance to detect short circuiting. (Implied to meet criteria).
Sterilization Method	Ethylene Oxide, Non-pyrogenic	Matches predicate (Ethylene Oxide, EO, Non-pyrogenic)
Physical and Dimensional Attributes (e.g., Overall Length, Core Electrode Diameter, Tip Style, Tip Taper)	Match predicate device (FHC microTargeting Electrode)	Ranges and descriptions provided match the predicate device.
Shelf Life	At least one year	One (1) Year (Aging study ongoing to obtain longer expiration date). Predicate has Three (3) Years.

The following points cannot be addressed by the provided document as they are related to AI/diagnostic studies, which are not applicable to this device and its submission type:

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/diagnostic device study. The "testing" mentioned refers to engineering and biocompatibility tests, not clinical evaluations with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established for a test set in the context of diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. No training set for an AI model.

9. How the ground truth for the training set was established: Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 15, 2017

Microprobes For Life Science, Inc. dba Neuron Julie Stephens President Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K162459

Trade/Device Name: Accupoint Electrode Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: May 15, 2017 Received: May 16, 2017

Dear Ms. Stephens:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K162459

Device Name AccuPoint™ Electrode

Indications for Use (Describe)

Neuron AccuPoint™ Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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MicroProbes for Life Science, Inc. dba Neuron Traditional 510(k) - AccuPoint™ Electrode

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.

Submitted By:	MicroProbes for Life Science, Inc. dba Neuron18247-D Flower Hill WayGaithersburg, MD 20879Phone: (301) 330-9788
Contact Person:	Julie Stephens, President/ConsultantRegulatory Resources Group, Inc.
Date Prepared:	June 8, 2017 - Revised

Device Name and Classification:

Trade/Proprietary Name:	AccuPoint™ Electrode	Common Name:	Depth Electrode
Classification Name:	Depth Electrode	Product Code:	GZL
Regulation:	21 CFR 882.1330	Class:	II

Legally Marketed Predicate Device:

FHC, Inc. - FHC microTargeting Electrode, 510(k) # K033173 & K991522 Reference device: Alpha Omega - Sterile Disposables for MER, 510(k) # K120098

Device Description:

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MicroProbes for Life Science, Inc. dba Neuron Traditional 510(k) - AccuPoint™ Electrode

Electrode with minimal confusion. Only a length within 5 cm of the AccuPoint Electrode comes into direct contact with patient tissue.

The AccuPoint Electrodes and Accessories will be sold sterile, for single patient use, and will be disposable.

Indications for Use:

Neuron AccuPoint™ Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain.

Characteristics	DeviceK162459	Predicate DeviceK033173; K991522
Device Name	AccuPoint™ Electrode	microTargeting® Electrode
Indications For Use	Neuron AccuPoint™ Electrodes areintended for use in intraoperativerecording of single unit neuronalactivity or intraoperative stimulation ofneural elements in the brain.	The FHC microTargeting Electrodesare intended for use in intraoperativerecording of single unit neuronalactivity or intra-operative stimulationof neural elements in the brain.
Anatomical Locations ofUse	Use in operating room forneurosurgical procedures whererecording of neuronal activity andstimulation of brain neurons will aid inthe placement of depth electrodes	Use in operating room forneurosurgical procedures whererecording of neuronal activity andstimulation of brain neurons will aid inthe placement of depth electrodes
Device Materials (Body Contact)
All Electrodes(Body Contact)	Stainless Steel TubingPolyimide ShieldingParylene C InsulationLoctite Medical Grade Adhesive	Stainless Steel TubingPolyimide ShieldingEpoxylite InsulationAdhesive
• Tungsten Electrodes	Core Electrode - Tungsten	Core Electrode - Tungsten
• Platinum IridiumElectrodes	Core Electrode - Platinum Iridium[80% and 20%] Alloy	Core Electrode - Platinum Iridium[80% and 20%] Alloy
Use with Other MedicalDevices	• Stereotaxic frame• Microdrive system• Connecting cables• Direct connection to microelectroderecording (MER) andmicrostimulation equipment	• Stereotaxic frame• Microdrive system• Connecting cables• Direct connection to microelectroderecording (MER) andmicrostimulation equipment
Use Condition Provided	Sterile, Single Patient Use[Not sold Non-Sterile]	Sterile, Single Patient Use• Also sold Non-Sterile
Method of Sterilization	Ethylene Oxide, EONon-pyrogenic [Electrodes andAccessories]	Ethylene Oxide, EONon-pyrogenic [Electrodes]Steam [Accessories]

Substantial Equivalence Matrix:

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Characteristics	Device(Proposed)	Predicate DeviceK033173; K991522
Physical and Dimensional Attributes [Comparison of AccuPoint Models to Equivalent FHC Models]
• Overall Lengths	235.24 to 291 mm(9.26 to 11.46 in)	235.24 to 291 mm(9.26 to 11.46 in)
• DiametersCore Electrode	0.200 to 0.250 mm(0.008 to 0.010 in)	0.200 to 0.250 mm(0.008 to 0.010 in)
• Electrode Tip Style	Straight Sharpened Point	Straight Sharpened Point
• Electrode Tip Taper	10-15 degree tip angle	10-15 degree tip angle
Electrode TipImpedance	0.5 MΩ-Megohms (+/-30%) to1 MΩ-Megohms (+/-20%) Measuredat 1 kHz or 220 Hz	0.5 MΩ-Megohms (+/-30%) to1 MΩ-Megohms (+/-20%) Measuredat 1 kHz or 220 Hz
Accessories	Within this Proposed 510(k)• Insertion and Spacer Tubes• StyletsTubes and Stylets made from 304Stainless SteelLength: Tip to Stop: 179 - 224 mm(7.05 to 8.82 in)Diameter: Varies by Model	510(k) # K121950 and # K092562• Insertion and Spacer Tubes• StyletsTubes and Stylets made from 304Stainless SteelLength: Tip to Stop: 179 - 224 mm(7.05 to 8.82 in)Diameter: Varies by Model
Expiration Date	One (1) Year¹	Three (3) Years

Substantial Equivalence Matrix (Continued):

Summary of Testing:

The biocompatibility risk assessment was completed as directed by FDA guidance under ISO 10993-1 biocompatibility requirements. Cytotoxicity testing was completed to demonstrate that the known biocompatible materials, the manufacturing processes, and the validated sterilization processes maintained compliance. Performance and safety testing completed for the AccuPoint Electrode included tests for electrode impedance, continuity and insulation integrity, and dynamic impedance to detect short circuiting between the inner and outer electrodes.

Substantial Equivalence Conclusions:

The completion of the testing demonstrates that the AccuPoint Electrode has the same principles of operation, indications for use, and technological characteristics as the predicate devices.

1 The Aging Study will be continuing to obtain a longer expiration date.

Regulation Number and Section

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).